Overview
Sponsor-declared trial summary
cardiac arrest, ventricular fibrillation
To demonstrate that add-on treatment with landiolol in patients with cardiac arrest significantly decreases the time to sustained ROSC (sROSC) (time from infusion of study medication to sustained ROSC)
Key facts
- Sponsor
- Medical University Of Vienna
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 30 Nov 2020 → ongoing
- Decision date (initial)
- 2024-12-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518949-14-00
- EudraCT number
- 2020-003661-19
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety
To demonstrate that add-on treatment with landiolol in patients
with cardiac arrest significantly decreases the time to sustained
ROSC (sROSC) (time from infusion of study medication to sustained
ROSC)
Secondary objectives 1
- outcome and survival, secondary safety outcomes
Conditions and MedDRA coding
cardiac arrest, ventricular fibrillation
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- OHCA , ³ 18 years of age • 3 or more shockable rhythms (VF or pVT) and last rhythm shockable
Exclusion criteria 1
- Age > 85a • Severe head trauma or acute active bleeding • Known allergy or insensitivity to landiolol or another b-blocker
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Time (in minutes) to sustained return of spontaneous circulation
Secondary endpoints 1
- cummulative ROSC, temporary ROSC, sustained ROSC, survival at 24h, favorable neurologic outcome
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Rapibloc 20 mg/2 ml Konzentrat zur Herstellung einer Injektionslösung
PRD4987941 · Product
- Active substance
- Landiolol Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- C07AB14 — -
- Marketing authorisation
- 137586
- MA holder
- AMOMED PHARMA GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Sodium Chloride Injection/Fresenius, 0,9% w/v, διάλυμα για έγχυση
PRD10732297 · Product
- Active substance
- Sodium Chloride
- Substance synonyms
- SODIUM CHLORID
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 10 ml millilitre(s)
- Max total dose
- 10 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- 41233/09/12-02-2010
- MA holder
- FRESENIUS KABI HELLAS SINGLE MEMBER S.A.
- MA country
- Greece
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medical University Of Vienna
- Sponsor organisation
- Medical University Of Vienna
- Address
- Spitalgasse 23, Alsergrund Alsergrund
- City
- Vienna
- Postcode
- 1090
- Country
- Austria
Scientific contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Department of Clinical Pharmacology
Public contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Department of Clinical Pharmacology
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 48 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2020-11-30 | 2021-03-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-518949-14-00_redacted | 3 |
| Protocol (for publication) | D1_Protocol 2024-518949-14-00_redacted track change | 3 |
| Recruitment arrangements (for publication) | Placeholder document_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_redacted | 2.1 |
| Summary of Product Characteristics (SmPC) (for publication) | Placeholder document for IB_upload in place of the IB | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-14 | Austria | Acceptable 2024-12-06
|
2024-12-10 |